Tandry CMF Plate System
Tandry CMF combines plates and screws for rigid fixation and reconstruction of facial bones. Its plates are commercially pure titanium, while the screws are Ti-6Al-4V titanium alloy. The…
Tandry CMF combines plates and screws for rigid fixation and reconstruction of facial bones. Its plates are commercially pure titanium, while the screws are Ti-6Al-4V titanium alloy.
The family includes plate sizes and shapes for different anatomical regions. A listed 2.0/2.3 mm compression plate belongs to the mandibular part of the range; other groups address the upper face, midface and orthognathic reconstruction.
Listed Item
2.0/2.3mm Compression Plate, 4H, Suitable 2.3mm screw
Plate and Screw Options
The 1.2 mm upper-face and 1.5 mm midface groups cover specified orbital, zygomatic and adjacent facial regions. The 2.0 mm mini plates cover midface or mandibular applications. Screw options include self-tapping, self-drilling, emergency self-tapping and locking designs.
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1), Shaanxi (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Kontour (Xi’an) Medical Technology Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 4 |
Record
| Listed by | Microware Precision Co., Ltd., Taiwan |
|---|---|
| FDA product code | JEY |
| Device type | Plate, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4760 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K220360 |
| Record published | 2026-05-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| T1-55-08230 | In distribution | |
| T1-55-28934 | In distribution | |
| T1-54-06262 | In distribution | |
| T1-55-06720 | In distribution | |
| T1-55-08204 | In distribution | |
| T1-55-28925 | In distribution | |
| T1-55-08206 | In distribution | |
| T1-55-08262 | In distribution | |
| T1-54-04002 | In distribution | |
| T1-55-06240 | In distribution | |
| T1-55-15920 | In distribution | |
| T1-55-06234 | In distribution | |
| T1-55-06767 | In distribution | |
| T1-55-15575 | In distribution | |
| T1-55-06771 | In distribution | |
| T1-55-08235 | In distribution | |
| T1-55-06260 | In distribution | |
| T1-55-06765 | In distribution | |
| T1-55-06206 | In distribution | |
| T1-55-06232 | In distribution | |
| T1-55-06236 | In distribution | |
| T1-55-06760 | In distribution | |
| T1-55-06238 | In distribution | |
| T1-55-06763 | In distribution | |
| T1-55-06250 | In distribution | |
| T1-55-05188 | In distribution | |
| T1-55-08260 | In distribution | |
| T1-55-06216 | In distribution | |
| T1-55-06254 | In distribution | |
| T1-55-06263 | In distribution | |
| T1-55-08216 | In distribution | |
| T1-55-15922 | In distribution | |
| T1-55-08233 | In distribution | |
| T1-55-15570 | In distribution | |
| T1-55-08251 | In distribution | |
| T1-55-15507 | In distribution | |
| T1-55-28920 | In distribution | |
| T1-55-06708 | In distribution | |
| T1-55-06220 | In distribution | |
| T1-55-08231 | In distribution | |
| T1-55-06237 | In distribution | |
| T1-55-08237 | In distribution | |
| T1-54-04005 | In distribution | |
| T1-55-28930 | In distribution | |
| T1-55-06724 | In distribution | |
| T1-55-15514 | In distribution | |
| T1-55-06560 | In distribution | |
| T1-55-06704 | In distribution | |
| T1-55-15580 | In distribution | |
| T1-55-06258 | In distribution | |
| T1-55-28911 | In distribution | |
| T1-55-06750 | In distribution | |
| T1-55-06208 | In distribution | |
| T1-55-08250 | In distribution | |
| T1-55-06212 | In distribution | |
| T1-55-06261 | In distribution | |
| T1-55-06235 | In distribution | |
| T1-55-06262 | In distribution | |
| T1-55-15506 | In distribution | |
| T1-55-06761 | In distribution | |
| T1-55-15505 | In distribution | |
| T1-55-06233 | In distribution | |
| T1-55-08203 | In distribution | |
| T1-55-06762 | In distribution | |
| T1-55-15524 | In distribution | |
| T1-55-06224 | In distribution | |
| T1-55-15504 | In distribution | |
| T1-55-05164 | In distribution | |
| T1-55-28917 | In distribution | |
| T1-55-15536 | In distribution | |
| T1-55-05152 | In distribution | |
| T1-55-06764 | In distribution | |
| T1-55-08205 | In distribution | |
| T1-55-05151 | In distribution | |
| T1-55-06231 | In distribution | |
| T1-55-15917 | In distribution | |
| T1-55-08232 | In distribution | |
| T1-55-06204 | In distribution | |
| T1-55-28932 | In distribution | |
| T1-55-06766 | In distribution | |
| T1-55-06754 | In distribution | |
| T1-55-28922 | In distribution | |
| T1-55-28926 | In distribution | |
| T1-55-08234 | In distribution | |
| T1-55-08240 | In distribution | |
| T1-55-08236 | In distribution | |
| T1-55-06270 | In distribution | |
| T1-55-15911 | In distribution | |
| T1-55-15585 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Plate, Bone | Stryker Leibinger Gmbh & Co. KG | 1,338 |
| Level ONE CMF | KLS-Martin L.P. | 1,160 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 843 |
| OsteoMed | Osteomed | 675 |
| Bioplate® | Bioplate, Inc. | 669 |
| Plate, Bone | Synthes Gmbh | 568 |
| Leforte System Bone Plate | Jeil Medical Corporation | 466 |
| CMF Visionare | Visionare LLC | 421 |
| Level ONE CMF, Sterile | KLS-Martin L.P. | 416 |
| Faico CMF System | Faico Medical, LLC | 361 |
| TraumaOne System | Biomet Microfixation | 357 |
| MatrixMANDIBLE | Synthes Gmbh | 277 |
Showing 12 of 152. All products under Plate, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220360 | 2022-11-10 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.